Brainlab Knee

• • Terminated Z-0959-2017 FDA Class II ·initiated 27 Oct 2016

  Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing

1. 4 Apr 2011 Cleared FDA 510(k) K102990
2. 27 Oct 2016 Recall initiated FDA recalls Z-0959-2017

510(k) Number

K102990 ↗

FDA product code

OLO

Device class

Class II

Regulation

21 CFR Part 882.4560

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

• CD HORIZON® Spinal System RBT023302 by MEDTRONIC SOFAMOR DANEK, INC.
• OMNIBotics NV-LPT02 by OMNIlife science, Inc.
• Spine Guidance Software, Stryker Q Guidance System by Stryker Leibinger GmbH & Co.KG
• V40 110765 by MAKO Surgical Corp.
• OMNIBotics NS-5036B by OMNIlife science, Inc.
• 6002-140-000 by Stryker Leibinger
• 6003-010-000 by Stryker Leibinger
• TMINI™ Miniature Robotic System by Think Surgical Inc.
• Joimax® Intracs® EM Patient Tracker JINTPT2235 by Joimax GmbH
• DYNAMIS™ Navigation System by PROMETHEAN RESTORATIVE

• Automatic Registration

  Class II

  FDA 510(k) K234047 Active Cleared 20 Mar 2024

• RT Elements (4.0)

  Class II

  FDA 510(k) K223279 Active Cleared 14 Mar 2023

• ENT Em

  Class II

  FDA 510(k) K223734 Active Cleared 27 Apr 2023

• Z-Touch

  Class II

  FDA 510(k) K003268 Active Cleared 22 Feb 2001

See all devices from Brainlab AG →